A Phase I Study of ORIC-101 plus Enzalutamide in Men whose Metastatic Prostate Cancer Worsened after Treatment with Enzalutamide Alone

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Full Title

An Open-Label Phase 1b Study of ORIC-101 in Combination with Enzalutamide in Patients with Metastatic Prostate Cancer Progressing on Enzalutamide

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

Enzalutamide is a standard drug used to treat CRPC. It works by blocking a protein called the androgen receptor. Eventually, prostate cancer becomes resistant to enzalutamide as well. One of the causes of resistance to treatment may be through a receptor called the glucocorticoid receptor. High levels of this receptor can cause cancer cells to grow during enzalutamide treatment. ORIC-101 is an investigational drug that blocks the glucocorticoid receptor.

Researchers think that blocking both testosterone and glucocorticoid activity will improve the response to treatment in men with metastatic prostate cancer. In this study, researchers are determining the highest dose of ORIC-101 that can be given safely with enzalutamide in men with metastatic CRPC that is growing on enzalutamide alone. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic CRPC that has continued to grow despite enzalutamide treatment.
  • At least 3 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients may not have received chemotherapy for metastatic disease nor apalutamide or darolutamide.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wassim Abida at 646-422-4633.

Protocol

19-475

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators